Pennsylvania Defective Medical Device Attorney

Medical Device Classification

Before a medical device can be used on patients, it must either be cleared or approved by the U.S. Food and Drug Administration (FDA). When the FDA clears a medical device, the agency reviews a previously filed premarket notification. Comparatively, a medical device can be approved by the FDA after a premarket approval application has been filed and reviewed. Whether a medical device needs to receive clearance or approval from the FDA depends on how it is classified.

Medical devices, according to the FDA, are classified into one of three categories, Class I, Class II and Class III, based on the risks they pose to patients. For example, devices categorized as Class I pose the least amount of risk to patients who use them. Because of this status, they are not subject to extremely strict regulatory measures. Comparatively, since Class III medical devices are considered to pose the highest level of risk to patients, these devices must receive approval from the FDA before they can enter the marketplace and even then they remain subject to stringent regulatory controls.

Defective Medical Device Recall

Medical devices can be recalled when one of two situations occurs. First, a medical device may be recalled when it is considered defective. Second, a medical device may be recalled if it poses a risk to the health of patients. In certain cases, medical devices are recalled when they are considered both a health risk and defective.

However, just because a medical device is recalled does not necessarily mean that the device maker will stop producing the product or that the product will be removed from the market entirely. For example, during a recall, a medical device may be inspected for issues, repaired in some way, re-labelled or adjusted. In some cases, a recall may simply involve the manufacturer of the medical device notifying patients that there is a problem with the device or have medical providers contact their patients to receive close monitoring while the device is still in use.

When a company discovers that their medical device has the potential to cause complications when used, they can either let the FDA know what is occurring or recall the devices themselves. However, in some situations, the FDA has to require the device makers to recall a medical device when the company refuses to remove the product from the market or make necessary changes after issues have been reported.

A Pennsylvania defective medical device lawsuit is an option for patients who suffered complications due to a defective medical device.